Preemptive Mavyret Therapy for Hepatitis C in Organ Transplant Recipients

Not currently recruiting at 1 trial location

Overseen By Rolland Dickson

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Disqualifiers: Chronic liver disease, HIV, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Mavyret, an antiviral medication, can prevent hepatitis C transmission from infected organ donors to uninfected recipients. It focuses on individuals receiving transplants such as kidneys, hearts, lungs, or pancreas from hepatitis C positive donors. The trial suits those on the transplant list for these organs, who do not have hepatitis C or other liver diseases, and are willing to receive organs from hepatitis C positive donors. As a Phase 4 trial, Mavyret has already received FDA approval and proven effective, offering participants the chance to benefit from a well-established treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for this treatment?

Research has shown that Mavyret, a combination of two drugs, is generally well-tolerated. Studies have found that Mavyret is safe and effective for individuals who have undergone liver or kidney transplants and are managing hepatitis C. These studies did not report any unexpected or severe side effects.

In a study with transplant patients, those using Mavyret experienced positive outcomes without serious issues, reinforcing confidence in its safety for these patients. The FDA has also approved Mavyret for treating hepatitis C in other cases, further supporting its safety.

Overall, the evidence suggests that Mavyret is a safe option for managing hepatitis C in organ transplant recipients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for Hepatitis C, which often involves longer treatment durations and more complex regimens, Mavyret offers a streamlined approach. Mavyret is unique because it combines glecaprevir and pibrentasvir, targeting multiple steps in the virus's life cycle, which can lead to a more effective viral clearance. Researchers are excited about Mavyret because it boasts a shorter treatment duration, typically just 8 weeks, making it potentially more convenient for patients. Additionally, its effectiveness across all major genotypes of Hepatitis C adds to its versatility, especially in the context of organ transplant recipients who are at higher risk of complications.

What evidence suggests that Mavyret might be an effective treatment for preventing HCV transmission in organ transplant recipients?

Research shows that Mavyret, a combination of glecaprevir and pibrentasvir, effectively treats hepatitis C. Studies indicate it cures the virus in 96.7% of cases, meaning the virus becomes undetectable in the blood. This high success rate appears in various groups, including those who have had organ transplants. Additionally, Mavyret is generally well-tolerated, with few serious side effects reported. In this trial, all participants will receive Mavyret as a preemptive treatment to prevent hepatitis C in organ transplant recipients, making it a promising choice for those concerned about contracting the virus from a donor. ^{1 2 6 7 8}

Who Is on the Research Team?

Bashar A Aqel

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for kidney, heart, lung, or pancreas transplant patients without chronic hepatitis C. Participants must be willing to accept a graft from a donor with hepatitis C and understand the risks of acquiring HCV infection. Those with chronic liver disease, pregnant women, or individuals with HIV or chronic hepatitis B cannot join.

Inclusion Criteria

Listed kidney, heart, lung and/or pancreas patients who are negative for chronic hepatitis C infection

Willing to accept and consent for accepting hepatitis C positive graft

Exclusion Criteria

Existing chronic liver disease (liver cirrhosis)

Pregnancy (Pregnant patients do not undergo solid organ transplants)

You or someone taking care of you do not understand or accept the risk of getting Hepatitis C during the course of the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-emptive Treatment

Participants receive combination therapy with Glecaprevir/pibrentasvir (G/P) and Ezetimibe to prevent HCV transmission

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including graft and patient survival

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Mavyret

Trial Overview

The study tests the effectiveness of Mavyret in preventing the transmission of Hepatitis C from an infected donor to a recipient who does not have Hepatitis C during organ transplantation.

How Is the Trial Designed?

Group I: Arm 1: Pre-emptive Treatment Arm Experimental Treatment 1 Intervention

Single arm study were all recipients of HCV viremic organs will receive combination therapy.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The combination of netupitant and palonosetron is effective in preventing both acute and delayed nausea and vomiting caused by moderately and highly emetogenic chemotherapy, as supported by phase II and III clinical trials.

This treatment offers a convenient single-capsule dosage and has a favorable side effect profile, although its high cost and administration logistics may pose challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of netupitant and palonosetron in chemotherapy-induced nausea and vomiting. Abramovitz, RB., Gaertner, KM.[2018]

A total of 228 adverse drug reaction reports were analyzed for nirmatrelvir/ritonavir (Paxlovid®) in France, with serious reports making up 40% of the cases, highlighting the importance of monitoring its safety profile, especially in older patients (mean age 66).

Drug-drug interactions (DDIs) were a significant concern, accounting for over 13% of reports, primarily involving immunosuppressive drugs, and the main unexpected adverse reactions included high blood pressure, confusion, acute kidney injuries, and skin reactions, necessitating careful management in patients on multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nirmatrelvir/ritonavir (Paxlovid®): French pharmacovigilance survey 2022. Bihan, K., Lipszyc, L., Lemaitre, F., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9679803/

A Pilot Trial for Prevention of Hepatitis C Virus ...

Prevention of HCV transmission may be preferable; several studies demonstrate 82.5%–100% success in prevention of HCV transmission with 4 weeks sofosbuvir/ ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6220874/

Glecaprevir/Pibrentasvir Treatment in Liver or Kidney ...

Safety and efficacy of current direct‐acting antiviral regimens in kidney and liver transplant recipients with hepatitis C: results from the HCV‐TARGET study.

3.

journals.lww.com

journals.lww.com/hep/fulltext/2025/03000/effectiveness_and_safety_of.26.aspx

Effectiveness and safety of glecaprevir/pibrentasvir for 8...

Eight-week G/P therapy was effective and well-tolerated in patients with acute HCV infection. Data support further investigation of G/P in acute HCV.

4.

journal-of-hepatology.eu

journal-of-hepatology.eu/article/S0168-8278(20)30072-6/fulltext

Real-world effectiveness and safety of glecaprevir ...

Glecaprevir/pibrentasvir achieved 96.7% virologic cure overall. Virologic cure was ≥95% across subgroups of interest. Serious adverse events were reported in 1 ...

5.

mavyret.com

mavyret.com/hcp/cure-rates

MAVYRET Cure rates and Clinical Study Designs

Learn about MAVYRET (glecaprevir/pibrentasvir) cure rates across all hepatitis C genotypes and multiple subpopulations. Learn about the indication, safety, ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04682509

NCT04682509 | A Single-center Pilot Study Evaluating a ...

The purpose of this research study is to evaluate the feasibility of a 2 week course of glecaprevir/pibrentasvir (Mavyret) starting immediately prior to ...

7.

myast.org

myast.org/uploads/files/general/16.-Hepatitis-C-2024.docx

16.-Hepatitis-C-2024.docx

This trial evaluated the safety and efficacy of glecaprevir/pibrentasvir for patients with chronic HCV GT1-6 infection who had received a liver or kidney ...

8.

hcvguidelines.org

hcvguidelines.org/guidance/treatment-of-hcv-uninfected-transplant-recipients-receiving-organs-from-hcv-viremic-donors/

Treatment of HCV-Uninfected Transplant Recipients ...

Of the 51 patients with complete treatment data, 64% were treated with glecaprevir/pibrentasvir and 36% received sofosbuvir/velpatasvir. All ...